MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. PRISMAFLEX M100 FILTER SET CONTINUOUS DIALYSIS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 01/24/2021

Event Type  malfunction  

Event Description

His patient had been on crrt since 0200 on (b)(6) 2021.At 1700 rn walked into patients room and noticed a large amount of bright red blood on the crrt machine and on the floor in front of the machine.There were no alarms associated with this event from the machine.The crrt machine was immediately paused for investigation.Rn discovered the tube that connects to the top of the filter was broken off the filter.This was noted to have happened 20 minutes prior to discovery since rn had been in the room performing the other task prior.There was also, a large amount of air noted in the tubing therefore the crrt machine was disconnected without the 150cc blood return.Ther had not been any significant changes to the settings on the machine or the fluid removal rate from the settings that it had been running the entire shift.There does not seem to be any harm to the patient and there was no visible air in the lines that were closest to the connection of the patient, only in the prefilter lines.New filter set was placed and crrt ran without complications.

• Brand Name: PRISMAFLEX M100 FILTER SET CONTINUOUS DIALYSIS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 11251027
• MDR Text Key: 229603282
• Report Number: MW5099093
• Device Sequence Number: 1
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Personal Care Assistant
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 106697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR